Bioavailability and Pharmacokinetics
Conditions
Keywords
milk thistle, silymarin, LipoMicel, pharmacokinetics, bioavailability, absorption, micelles
Brief summary
This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.
Interventions
DIETARY_SUPPLEMENTLipoMicel Milk Thistle
A maximum single dose of approx. 140 mg silymarin (in soft gel capsule)
DIETARY_SUPPLEMENTUnformulated Milk Thistle Extract
A maximum single dose of approx. 130 mg silymarin (in hard gel capsules)
Sponsors
Isura
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 21- 65 years * Healthy, good physical condition * Voluntary, written, informed consent to participate in the study.
Exclusion criteria
* Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases * Contraindication or allergies to milk thistle * Pregnancy or breastfeeding * Concurrent use of supplements and/or medications * Participation in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing silymarin. |
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing silymarin. |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing silymarin. |
| MRT: Mean residence time | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the mean residence time (MRT) with that of other capsules containing silymarin. |
| T1/2: elimination half-life | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the elimination half-life (T1/2) with that of other capsules containing silymarin. |
Countries
Canada
Outcome results
None listed